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1015463

NYU Langone Health, Transplantation & Cellular Therapy — FEI 2470026

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 18, 2017
Fiscal Year
2017
Product Type
Biologics
Project Area
Blood and Blood Products
Location
New York, NY (United States)

Facility

Other inspections at this facility

  • 1274509 (NAI Fri Jun 27 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1250142 (VAI Thu Sep 26 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1177868 (NAI Fri Aug 19 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 922842 (VAI Thu Apr 09 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 822206 (VAI Mon Mar 25 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
15421 CFR 606.160(a)(1)Concurrent documentation
15521 CFR 606.160(b)Required records
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
8721 CFR 606.100(b)(8)Methods for pre-transfusion testing